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FDA Approval

Hogan Lovells

HHS proposal to exempt medical devices from 510(k) process halted

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On January 15, the U.S. Department of Health and Human Services (HHS) published a notice and request for information (RFI) proposing to exempt 91 medical devices – for which the normal regulatory process was temporarily...more

Benesch

Dialysis & Nephrology Digest - January 2021

Benesch on

Congress’ year-end spending bill includes increase to Medicare physician fee schedule, surprise medical bill protection - Sweeping federal legislation signed into law on Dec. 27 combines $1.4-trillion in spending...more

American Conference Institute (ACI)

[Virtual Event] 36th Annual FDA Boot Camp - March 24th - 25th, 8:15 am - 1:45 pm EDT

ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more

Goodwin

Year in Review: Top-Five U.S. Biosimilar Market Developments of 2020

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As we ring in the new year, we look back at the top U.S. biosimilar market developments of 2020. Here are some of our highlights, in no particular order...more

Morgan Lewis

FDA’s End-of-Year Gifts: COVID-19 Diagnostic Tests and Collection Devices for Home Use

Morgan Lewis on

The Food and Drug Administration (FDA or the Agency) spent the remaining weeks of 2020 issuing Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC...more

BakerHostetler

COVID-19 Vaccine: Simplifying the Complex Life Cycle of the Vaccine

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On today’s episode, we explore the complex life cycle of the COVID-19 vaccine and some common questions surrounding the authorization, distribution and administration of the vaccination....more

Hogan Lovells

Coronavirus: The Hill and the Headlines, December 2020 # 14

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In Washington: With only hours to spare, House and Senate lawmakers were forced to pass a last-minute short-term extension of government funding (H.J. Res. 107) to stave off a government shutdown while congressional...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, December 2020 # 13

Hogan Lovells on

In Washington: Top Senate Republicans indicated on Thursday that Congress is increasingly likely to need a brief stopgap government funding bill lasting several days to clinch a spending and coronavirus relief deal. Friday...more

Perkins Coie

A COVID-19 Vaccine Is on the Way—Considerations for Employers and Their Workforces

Perkins Coie on

A COVID-19 vaccine authorized by the U.S. Food and Drug Administration (FDA) for emergency use has arrived in the United States and is being widely distributed to select groups as we issue this update. It is more than likely...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, December 2020 # 12

Hogan Lovells on

In Washington: The “four corners”— House Speaker Nancy Pelosi (D-CA), House Minority Leader Kevin McCarthy (R-CA), Senate Minority Leader Chuck Schumer (D-NY), Senate Majority Leader Mitch McConnell (R-KY)—are reportedly...more

Seyfarth Shaw LLP

FDA Issues Emergency Use Authorization for COVID-19 Vaccine

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On December 11, 2020, FDA issued the first emergency use authorization (“EUA”) for a vaccine to prevent COVID-19. The vaccine, developed by Pfizer-BioNTech, is authorized for those 16 years of age and older....more

Hogan Lovells

Coronavirus: The Hill and the Headlines, December 2020 # 9

Hogan Lovells on

In Washington: The Senate passed a one-week stopgap bill on Friday, hours ahead of a government shutdown deadline. The bill passed on a voice vote and moved the funding deadline to December 18. The continuing resolution...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, December 2020 # 8

Hogan Lovells on

In Washington: The Food and Drug Administration’s (FDA) vaccine advisory panel voted to recommend that the FDA authorize the Pfizer-BioNTech vaccine for emergency use. A Centers for Disease Control and Prevention (CDC)...more

Stotler Hayes Group, LLC

6 Things LTC Providers Need to Know About the COVID-19 Vaccine on the Cusp of Its US Approval

Stotler Hayes Group, LLC on

Since COVID-19 strong-armed its way to the forefront of the US media in March 2020, we’ve seen hundreds, even thousands of news stories, opinion pieces, and agency reports on related topics ranging from its impact on schools...more

Foley & Lardner LLP

Historic FDA Advisory Committee Vote on Pfizer and BioNTech’s COVID -19 Vaccine

Foley & Lardner LLP on

The FDA’s Vaccines and Related Biological Products Advisory Committee voted 17 to 4 with 1 abstention and 1 no vote that based upon the available scientific evidence, the benefits of the Pfizer and BioNTech’s COVID-19 vaccine...more

Hogan Lovells

Looking ahead to 2021: AI – A brave new world?

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In recent years, AI has become a buzzword in life sciences and health care as the technology has developed to create applications from drug discovery to diagnostics to therapeutics. Most recently, AI has been used in the...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, December 2020 # 5

Hogan Lovells on

In Washington: President-elect Joe Biden picked California Attorney General Xavier Becerra to be his health secretary. Becerra was a defender of the Affordable Care Act. Separately, Biden picked a Harvard infectious...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, December 2020 # 2

Hogan Lovells on

In Washington: Congress continues to debate a new coronavirus relief package, possibly as part of a government spending bill due December 11. Here are the latest developments...more

Hogan Lovells

HHS ends FDA Unapproved Drugs Initiative, seeks to limit which drugs require FDA approval

Hogan Lovells on

On November 20, 2020, the U.S. Health and Human Services Department (HHS) announced that the Department was terminating the Food and Drug Administration’s (FDA) Marketed Unapproved Drugs Initiative (UDI)....more

Burr & Forman

COVID-19, Mobile Health & the Importance of Maintaining Legal Compliance in an Era of Explosive Growth

Burr & Forman on

It is increasingly important for mobile app developers to ensure their products comply with all governing state and federal laws, and it is critical to understand which business changes might place your product under a...more

Morgan Lewis - As Prescribed

HHS Ends FDA’s Unapproved Drugs Initiative – At Least For Now

In an apparent effort to combat prescription drug shortages and price spikes, the US Department of Health and Human Services (HHS) recently announced the forthcoming termination of FDA’s Unapproved Drugs Initiative (UDI). ...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

In Tuesday's Report: a panel discussion on the U.S. election, Americans warned of COVID-19 surge, Moderna files for FDA EUA, Hong Kong proposes corporate rescue bill, new Foreign Direct Investment rules in Spain, the EU moves...more

Bricker & Eckler LLP

Will you be ready when the COVID-19 vaccines arrive?

Bricker & Eckler LLP on

‘Tis the season to be jolly! This holiday season may be merrier if the recently announced COVID-19 vaccination candidates obtain approval and/or authorization for use in preventing COVID-19 by the U.S. Food and Drug...more

Hogan Lovells

Election 2020 Snapshot: Impacts of the U.S. election for the life sciences and health care industry

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On November 19, leaders of our Life Sciences and Health Care team met for a panel discussion of the impacts on the industry of the 2020 U.S. election. This was the first event in a series of conversations, with other webinars...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

Tuesday, 24 November 2020 - U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug...more

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